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Clinical Trials/NCT02523456
NCT02523456CompletedNot Applicable

Develop, Implement and Assess Effectiveness of Early Warning Score (EWS) for Moneragala District General Hospital

Ministry of Health, Sri Lanka1 site in 1 country18,000 target enrollmentStarted: May 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
18,000
Locations
1
Primary Endpoint
Proportion of in-hospital cardiac arrests

Study Overview

Brief Summary

Rationale: Early detection and timely interventions are important determinants of clinical outcome in people with acute illness. Adverse outcomes including unplanned transfer to intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based on bedside vital sign observations may help early detection, improve outcome of patients and reduce healthcare cost.

EWS which are effective in predicting deteriorating patients developed in high income countries have been shown to lose sensitivity and specificity when applied to a low income setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are positive, widespread adaptation of these scores can significantly contribute to improved patient outcome, better utilization of ICU services and cost effective healthcare provision.

Objectives: To describe the demographic characteristics of cardiac arrest patients and the availability of physiological variables for calculation various EWSs in DGH, Moneragala To validate an early warning score suitable for patients at DGH, Moneragala To examine the effectiveness of the selected EWS at improving pre-defined patient outcomes

Proposed methodology:

Study I: All clinical variables and patient characteristics of past two years collected retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before cardio respiratory emergency and at admission to hospital will be extracted. The availability of variables required for the calculation of various EWSs will be noted.

Study II: All consecutive inpatient admissions for three months to all units except intensive care unit at DGH, Moneragala will be included to the study, prospectively. Data will be collected from bed head tickets using pre-defined data sheets by nominated medical/ nursing officers daily. Demographic details and physiological data will be recorded on admission to ward. Physiological data for seven EWS will be collected twice daily by these medical/nursing officers.

Study III: Training will be given for the staff to identify patients getting worse using the newly validated EWS. The outcome of this will be measured with information obtained from Study II.

Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine, University of Colombo (EC-15-034).

Detailed Description

Introduction: Early detection and timely interventions are important determinants of clinical outcome in people with acute illness. Adverse outcomes including unplanned transfer to intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based on bedside vital sign observations may help early detection, improve outcome of patients and reduce healthcare cost.

Effectiveness of EWS in predicting deterioration of seriously ill patients has been demonstrated in high income countries (HICs). However, these scores developed in HICs have been shown to lose sensitivity and specificity when applied to a low income setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are positive, widespread adaptation of these scores can significantly contribute to improved patient outcome, better utilization of ICU services and cost effective healthcare provision.

The study will take place in district general hospital (DGH) Moneragala, in Sri Lanka, a lower middle income country (LMIC). The hospital has nearly 450 beds and over 800 staff members serving over 50000 patients per year and approximately 500 cardiac arrests per year. It has four medical wards, two surgical wards and 5 other wards. A wedge shaped interventional study was designed to investigate whether a "setting tested" early warning system protocol can be implemented in a rural district general hospital of a LMIC using a local TTT model to reduce cardiac arrests and admissions to ICU.

Objectives

  • To describe the characteristics, including EWS, of patients resuscitated at DGH, Moneragala.
  • To validate a suitable EWSs at DGH, Moneragala.
  • To examine the effectiveness of the validated EWS as part of a training and implementation bundle to reduce the incidence of cardiac arrests, ICU admissions and mortality.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who underwent CPR.
  • •Attendance of cardiac arrest team at this emergency. (When a cardiac arrest occurs in this hospital a cardiac arrest team attends)
  • •Age more than 18 years.

Exclusion Criteria

  • •Patients who were under Do Not Resuscitate (DNR) instructions.
  • •Patients admitted to ICU.

Arms & Interventions

Introduce EWS and Training on EWS

Experimental

The group of patients who admitted to a ward where the staff has trained on EWS and EWS has been introduced.

Intervention: Training (Behavioral)

Introduce EWS and Training on EWS

Experimental

The group of patients who admitted to a ward where the staff has trained on EWS and EWS has been introduced.

Intervention: Introduce EWS (Behavioral)

EWS not introduced

No Intervention

The group of patients who admitted to a ward where the staff has no special training on EWS and EWS has not been introduced.

Outcomes

Primary Outcomes

Proportion of in-hospital cardiac arrests

Time Frame: Twelve months

Reduction of proportion of in-hospital cardiac arrests among admitted patients

Secondary Outcomes

  • Proportion of in-hospital deaths following cardiac arrests(Twelve months)
  • Proportion of ICU admissions following cardiac arrests(Twelve months)

Investigators

Sponsor
Ministry of Health, Sri Lanka
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Pubudu De Silva

Project coordinator

Ministry of Health, Sri Lanka

Study Sites (1)

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